The medical device industry and FDA are in the final stages of an agreement on medical device user fees, closing in on a package that includes around $600 million in fees over five years and abandons recent proposals to hike fees in the middle of the program, several sources said.

House Republican lawmakers are poised to set medical device user fees at their current rate for one or two years if FDA and industry fail to come to an agreement on the fees in time to move the entire user fee package, a key Energy and Commerce lawmaker said Wednesday (Jan. 25). FDA and industry, however, are closing in on an agreement after months of debate over fee levels, although it has not been finalized (see related story).

The Biotechnology Industry Organization's top official said the group is poised to defend the biosimilars component of the Affordable Care Act in the event the Supreme Court or Congress strikes down the entire law, billing it as a potential fight in 2013 to ensure the new pathway's provisions remain intact, and the Generic Pharmaceutical Association warned preventing development of the pathway could bankrupt the healthcare system. A generic drug industry attorney expressed concern that a move by Congress to reconsider the health reform law could leave controversial provisions such as the biosimilars pathway vulnerable to change, as biologics exclusivity has been widely debated since the law's passage.

Biotechnology Industry Organization officials said Monday (Jan. 23) that they are shifting their focus toward reforming FDA's accelerated approval process, a departure from the creation of a new progressive approval pathway, which was met with some opposition from FDA and some in industry. BIO officials said they are still pursuing an expansion of endpoint usage, but reforming the current system -- as opposed to establishing a new one -- would ensure a smoother transition for the agency while quelling concerns raised about setting a new safety standard.

Former and current FDA officials said without unique device identifiers Sentinel efforts will focus more on biologics and create obstacles for device inclusion in the surveillance program, although a safety advocate said other device information could be used to track the products. A Premier healthcare alliance official said the UDI rule is likely caught up in review at the White House Office of Management and Budget because of industry concerns about the cost, but the organization has been pushing for it to be released for comment.

Free speech advocates are using a district court case as an opportunity to challenge FDA guidance released last year outlining the difference between drugs and devices, with the advocates saying the agency's policy conflicts with the statutory definition of medical devices. The draft guidance documents -- including one saying any product that brings about a chemical action is a drug -- could cause some medical products previously classified as devices to be reclassified as drugs, attorneys said, adding that these documents show the agency is changing its interpretation of the difference between the two products.

Some physician groups are lobbying against legislation that would make continuing medical education mandatory for opioid prescribers, saying such a mandate could restrict access to these products by creating a burden on doctors. A recent Government Accountability Office report on prescription drug abuse also highlights the American Medical Association's push for incentives, as opposed to mandates, to increase prescriber education efforts, although the group maintains there is an unclear link between prescribing practices and drug diversion.

Industry stakeholders said an FDA-regulated system for front-of-package labels could limit free speech if such an approach banned companies from using other labeling systems, and a free speech advocate said the agency could only bar companies from using labels if it found they listed misleading information. The dialogue emerges as FDA evaluates recent Institute of Medicine recommendations to develop a government-mandated FOP labeling that would prohibit all other FOP systems.

Safety advocates are gearing up to push for inclusion of medical device safety reforms as part of user fee legislation as key Democrats also set the groundwork for measures aimed at increasing oversight of implantable devices. But sources said medical device safety measures could be a difficult sell as lawmakers increasingly focus on reducing regulation to promote innovation in the medical device sector.

Democratic leaders of the House Energy and Commerce Committee have renewed their call for hearings to examine the safety of implantable medical devices ahead of reauthorization of medical device user fees, an area where safety advocates are pushing for a more rigorous premarket approval process.

A bipartisan group of senators is working on a broad, permanent solution to address the root cause of drug shortages, with these solutions possibly including tax incentives and other market incentives to encourage manufacturers to make medications experiencing shortages, Sen. Amy Klobuchar (D-MN) said in a speech on the Senate floor Thursday (Jan. 26), while also citing financial decisions in the pharmaceutical industry as a "major factor in drug shortages."

The FDA food center's top official said that a rule on the accreditation of third-party auditors for high-risk imports will lag behind other food safety law regulations because the responsibility is new territory for the agency. An industry attorney questioned the agency's ability to implement such an audit program, given its history of using third parties on other regulated products such as medical devices.

Stakeholders said the two preventive control rules under review at the White House Office of Management and Budget could shift FDA's inspections from an observational to auditing role because they will allow increased access to facility records. Industry stakeholders said although the rules are not out yet, companies should prepare for changes on domestic and foreign inspections such as having personnel trained to address inspector questions.

The Department of Justice Wednesday (Jan. 25) filed a groundbreaking consent decree against Ranbaxy Laboratories, the India-based generic drug maker that last year gained approval to market generic Lipitor. While an FDA spokesperson said the filing does not limit the company's ability to sell the widely prescribed atorvastatin, Ranbaxy would relinquish any six-month marketing exclusivity for three pending generic drug applications and several additional applications if it does not meet the decree's requirements by specified dates.

A coalition of mobile health companies is pressing FDA to revamp its draft guidance on mobile medical applications to better define topics like accessories, wellness claims and electronic health records, and said the overhauled guidance should then go through a second comment period. The draft guidance's vague treatment of mobile medical devices is discouraging companies from entering the market and hindering enforcement in this new area, an industry attorney said.

FDA used its new administrative detention authority three times during the first year of the Food Safety Modernization Act, while mandatory recall and registration suspension powers remained unused, FDA and industry sources said. An industry attorney said the detention authority might have been used more than the other new authorities because it has a lower standard for evidence, while a food safety advocate applauded FDA's efforts to quickly use the new power.

The Medicines Company has resolved all litigation surrounding certain patents for its anti-coagulant Angiomax, the company said as it announced a patent settlement that included a licensing agreement with APP Pharmaceuticals. The product's patent extensions were a high-profile topic for several years, including during last year's patent reform debate, which eventually led Congress to mandate an extension and clarify confusion surrounding filing deadlines.

The House Energy and Commerce Committee held 109 hearings in 2011, committee leadership said in a progress report that touted health reform oversight, as well as the panel's oversight of FDA, including progress on an investigation into the 2008 heparin contamination. The committee is gearing up to tackle four user fee agreements with three hearings scheduled next month on the topic.

The House Energy and Commerce Committee will focus on early notification mechanisms and Drug Enforcement Administration quotas as it pursues legislation to stem drug shortages, with a congressional source saying debate around reimbursement changes is ongoing but the committee will wait until a February hearing on generic drug user fees -- where the issue will be discussed -- before determining if reimbursement changes are needed to stem the drug dearths.

The Senate Special Committee on Aging may reschedule a hearing on CMS implementation of the Physician Payments Sunshine Act for this spring, a committee staff member said on Tuesday (Jan. 24), adding that the committee will work with the agency this spring and summer to ensure timely implementation of the law and that stakeholder concerns are addressed.

An official from the Federal Trade Commission said words like "clinically proven" and "physician recommended" are raising red flags for the agency when investigating false claims in advertising, saying such cases, including drug claims in food advertising, are increasing as companies try to profit from nutrition trends like probiotics. A free speech advocate said that FTC's pursuit of misleading advertisements, while imposing fewer limits than FDA on what companies can say, is a model that FDA should follow.

The health reform law's comparative effectiveness research advisory board unveiled a draft research agenda that does not include specific conditions or treatments, opting instead to outline general, vaguely worded research topics. Stakeholders say they wish the Patient-Centered Outcomes Research Institute had been more specific in its research agenda, which will form the foundation of PCORI's funding announcements.

President Barack Obama's newly released plan to make global supply chains more efficient and safe falls in line with FDA efforts in food and drug security, such as increasing collaborations with foreign regulators, and could bolster efforts to push legislative reforms during drug user fee reauthorization, stakeholders said. The plan comes on the heels of the president's State of the Union address where he touched on medical device and food safety, and pushed for increased inspections to crack down on counterfeit products.